Regulatory Writer

Are you passionate about understanding the needs of medicines authorities and re-writing our internal documentation into regulatory submissions? Do you have experience in the regulatory field and/or within API production processes or analytical chemistry, you might be the perfect fit for our Regulatory Writer position.

The position
As a Regulatory Writer, you will take charge of defining the regulatory storyline and creating documentation for all our synthetic platforms within the analytical- and API process part of our regulatory documents. 

This includes:

• Writing and reviewing documents for regulatory submissions such as analytical procedures and analytical method validation reports
• Writing and reviewing documents for regulatory submissions on our synthetic API manufacturing processes. Participate in answering questions from health authorities worldwide in close collaboration with colleagues across various departments – e.g. Global Contract Manufacturing, CMC, Quality Control, Quality Assurance, Manufacturing facilities and Regulatory Affairs. 

This role offers an exciting and stimulating opportunity that requires curiosity, responsibility, initiative, collaboration skills, and flexibility. 

Qualifications
To be successful in this role, we are looking for someone who ideally has: 

• A master’s degree within Pharmacy, Chemistry, Engineering, or a similar field.
• Knowledge about Analytical Chemistry or API production processes.
• Experience either from Health Authorities e.g., Danish Medicines Agency, the pharmaceutical industry or the regulatory area with writing or reviewing regulatory documents.
• A passion for writing and strong writing skills in English.
• Good organizational and task prioritization skills.

 
As a person you are curious, and challenges do not scare you. You have a structured and detail-oriented approach to everything you do, and you never compromise on quality. You enjoy being part of a team and you excel at time management.

About the department

As part of Novo Nordisk’s Product Supply organization, you will be assigned to Emerging Technologies API Manufacturing Development (ET API MDev). We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management.  
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment. 
The department is newly established, presenting a unique opportunity to join at the beginning of an exciting journey, while benefiting from the established way of working in Novo Nordisk.

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing mas-sively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 72,000 employees around the world. We recognize the importance of the unique skills and perspec-tives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us! Together, we go further. Together, we're life-changing.

Contact
If you have any questions about the job, please don’t hesitate to contact Sr. Manager, Camilla Christensen, cmsc@novonordisk.com. 

Deadline
19 May 2025

You do not need to attach a cover letter to your application, but please include a few sentences in your resume or CV about why you are applying for the job. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.
 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.